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NCT02089100Active, not recruitingPhase 3

Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer

Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment

Source: ClinicalTrials.gov · Last updated 19 Mar 2026

Brief summary (registry, in English)

The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: "de novo", i.e. occurring at first metastatic presentation without any previous systemic therapy; and "secondary", defined as residual disease after systemic treatment. The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease. This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
154 (actual)
First submitted
13 Mar 2014
Start date
26 Feb 2014
Primary completion date
Oct 2033
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
NCT number
NCT02089100

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 154
  • From 26 Feb 2014 to the primary completion date, Oct 2033
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Biopsy proven breast cancer stage IV AJCC TNM
  • Age \>18 years
  • WHO status≤2
  • Hormonal receptors positive breast cancer (IHC)
  • The primary tumor was treated or will be treated with curative intent (surgery and/or radiotherapy)"
  • No new treatment for metastatic relapse Prior history of adjuvant hormonotherapy or relapse under adjuvant hormonotherapy are not exclusion criteria.
    • It will be accepted patients which would have begun new line of systemic treatment in the case where:
    • Hormonotherapy or CDK4/6 inhibitors ≤ 3 months.
    • Chemotherapy or immunotherapy ≤ 2 cycles. If SBRT arm: The treatment (except hormonotherapy by aromatase inhibitor and/or LHRH agonist) must be interrupted during the completion of radiotherapy.
  • Metastatic lesions out of previous radiation field b. Equal or less than 5 metastatic lesions (measurable or not) c. In case of measurable lesions, each ≤10 cm or ≤500 mL 8. For liver mets:
  • adequate liver function (liver enzyme \<3N, bilirubin\<30mg/dl, albumin\>2.5g/dl),
  • no underlying cirrhosis or hepatitis
  • liver metastase size ≤7cm diameter
  • not adjacent to stomach or small bowel 9. For abdominal mets:
  • Adequate renal function with a creatinine clearance (Cockroft formula) \> 60ml/min 10. Absence of any psychological, familial, sociological or geographical condition with a potential to hamper compliance with the study protocol and follow-up schedule 11. Life expectancy \> 3 months 12. Affiliated to Health Insurance regimen 13. Written and signed consent form
    • Non-inclusion Criteria:
  • Triple negative breast cancer
  • Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide)
  • Brain metastases
  • In spinal cord mets:
    • More than 3 consecutive and contiguous spinal segments involved by tumor
    • Neurological examination prior randomization \>1 week
    • Inability to tolerate treatment (unable to lie flat)
    • Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
    • Significant or progressive neurological deficit
    • More than 25% spinal canal compromise
    • Malignant epidural spinal cord compression or cauda equina syndrome
    • Spine instabilityor neurological deficit resulting from bony compression of neural structures
  • Scleroderma or connective tissue disease as a contraindication to radiotherapy
  • Pregnancy or breast feeding period

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institut Sainte-Catherine
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AvignonFranceUnknown status
Centre François Baclesse
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CaenFranceUnknown status
Georges François Leclerc
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DijonFranceUnknown status
Centre Oscar Lambret
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LilleFranceUnknown status
Hôpital Nord
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MarseilleFranceUnknown status
Institut Paoli-Calmettes
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MarseilleFranceUnknown status
CHU La Timone
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MarseilleFranceUnknown status
ICM Val d'Aurelle
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MontpellierFranceUnknown status
Centre Antoine Lacassagne
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NiceFranceUnknown status
Centre Eugène Marquis
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RennesFranceUnknown status
Henri Becquerel
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RouenFranceUnknown status
Institut de Cancérologie de l'Ouest
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Saint-HerblainFranceUnknown status
Institut de Cancérologie de l'Ouest - René Gauducheau
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Saint-HerblainFranceUnknown status
Centre de Cancérologie Paris Nord
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SarcellesFranceUnknown status
Centre Paul Strauss
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StrasbourgFranceUnknown status
Centre de Radiothérapie de la Robertsau
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StrasbourgFranceUnknown status
Hopital Bretonneau
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ToursFranceUnknown status
Gustave Roussy Cancer Campus, Grand Paris
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VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.